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Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256866
Recruitment Status : Unknown
Verified November 2010 by Hospital Sao Domingos.
Recruitment status was:  Recruiting
First Posted : December 9, 2010
Last Update Posted : December 9, 2010
Information provided by:
Hospital Sao Domingos

Brief Summary:
The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)

Condition or disease Intervention/treatment Phase
Mechanically Ventilated Patients Sedation Dexmedetomidine Midazolam Drug: Dexmedetomidine Drug: Midazolam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Study Start Date : November 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: DEXMEDETOMIDINE, SEDATION Drug: Dexmedetomidine
Active Comparator: Midazolam, sedation, Drug: Midazolam

Primary Outcome Measures :
  1. Incidence of delirium

Secondary Outcome Measures :

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult mechanically ventilated, critically ill patients

Exclusion Criteria:

  • pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256866

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Hospital Sao Domingos Recruiting
Sao Luis, Maranhao, Brazil, 65060-100
Contact: Jose R Azevedo, MD    55 98 32168110   
Principal Investigator: Jose R Azevedo, MD         
Sub-Investigator: Carla C Oliveira, RN         
Sponsors and Collaborators
Hospital Sao Domingos

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Responsible Party: Ethics Committee, Hospital Sao Domingos Identifier: NCT01256866    
Other Study ID Numbers: hsd130947
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: November 2010
Keywords provided by Hospital Sao Domingos:
Mechanical ventilation
Critically ill patients
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents